New Therapeutic Strategies for Inhibitory Control in Alcoholism

Not Applicable

Completed

• Conditions: Alcoholism
• Interventions: Behavioral: Retrieval-Extinction Learning; Other: rTMS; Other: SAM

• Registration Number: NCT03058276
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief Summary

This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.

Detailed Description

The main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified Stop signal task): a behavioral treatment based on Retrieval-Extinction Learning, through the AAT (Alcohol Approach Avoiding Task) and a treatment based on the neuromodulation of prefrontal cortex through the rTMS (repetitive transcraneal magnetic stimulation) technique. To carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (UPPS) and behvavioral impulsivity (Stop signal task), along with biological measures for polymorphism determinations. Alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for Retrieval-Extinction Learning with AAT and 2:1 (double for the effective technique comparing to placebo/control) for rTMS): Group 1 (N=30): exposure to an alcohol-related video followed by AAT; Group 2 (N=30): neutral-content video followed by AAT; Group 4 (30): active stimulation rTMS (10 Hz) ; Group 4 (N=15): placebo stimulation SAM.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Primary Completion: 2020-09
• Study Completion: 2020-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Men and women aged between 18 and 50 years old.
• A minimum of 28 days of abstinence
• Consent to participate in the study.

Exclusion Criteria

• Subjects with other substance dependence ( with the exception of tobacco)
• Subjects with a history of brain injury or neurological diseases
• Denial for study participation
• Non-spanish speakers
• rTMS selected participants with be assed in order to discard epilepsy, presence for metallic elements and CNS valves

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No exposure	Retrieval-Extinction Learning	Exposure to a 5 minutes video with neutral content (no retrieval) followed by 10 minutes of the alcohol- AAT (Approach Avoidance Task) , during 4 days of training.
Exposure	Retrieval-Extinction Learning	Exposure to a 5 minutes video related to alcohol consumption (updating/retrieval), followed by 10 minutes of the alcohol- AAT(Approach Avoidance Task) (extinction), during 4 days of training (2 weeks).
Active rTMS	rTMS	Each session (5 sessions along 2 weeks), patients receive active stimulation with repetitive transcraneal magnetic stimulation (rTMS) of the right dorsolateral prefrontal cortex.
SAM	SAM	Pacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition

Primary Outcome Measures

Name	Time	Method
Heavy drinking	3 months	Number of days of heavy drinking
Relapses	3 months	Number of relapses
Abstinence	3 months	Days of accumulated abstinence

Secondary Outcome Measures

Name	Time	Method
Self-reported Impulsivity	2 days	scores for UPPS
Behavioral Impulsivity	2 days	Stop signal task reaction times
Polymorphism distribution of CRH and ANK3 genes	2 days	Biological determinations-lymphocyte samples

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain